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Archive - 02 - 2012
American Diabetes Association Statement on Recent FDA Safety Changes in Labeling for Some Cholesterol-Lowering Drugs
February 29, 2012 (Market Wire) Yesterday, the U.S. Food and Drug Administration (FDA) announced safety changes in the labeling for some cholesterol-lowering drugs (statins). According to the FDA's safety announcement, the products include: Lipitor, Lescol, Mevacor, Altoprev, Livalo, Pravachol, Crestor and Zocor. Combination products include: Advicor, Simcor, and Vytorin.In a statement, the FDA said, "Increases in blood sugar levels (hyperglycemia) have been reported with statin use. The FDA is also aware of studies showing that patients being treated with statins may have a small increased risk of increased blood sugar levels and of being diagnosed with type 2 diabetes mellitus."While there is evidence that statins can increase the risk of diabetes, the American Diabetes Association urges people with diabetes who are currently taking a statin to continue their medication unless instructed otherwise by their healthcare provider. Stopping these medications may increase the risk of diabetes-related heart attacks. "Every drug has its risks and benefits, and with statins the risk is small and can be managed," said Vivian Fonseca, MD, President, Medicine & Science, American Diabetes Association. He adds, "On the other hand, people with diabetes, can receive great benefit from taking these medications. They've been proven to prevent heart attacks and prolong life."It is important to be aware of the risks and benefits of any medication. Patients with concerns or questions about their statin medication, or any other medication, should ask their physician, pharmacist, or other members of their health care team for more information. The American Diabetes Association continues to support the FDA in its role as the regulatory agency that makes decisions regarding drug safety and efficacy.The American Diabetes Association is leading the fight to stop diabetes and its deadly consequences and fighting for those affected by diabetes. The Association funds research to prevent cure and manage diabetes; delivers services to hundreds of communities; provides objective and credible information; and gives voice to those denied their rights because of diabetes. Founded in 1940, our mission is to prevent and cure diabetes and to improve the lives of all people affected by diabetes. For more information please call the American Diabetes Association at 1-800-DIABETES (1-800-342-2383) or visitwww.diabetes.org. Information from both these sources is available in English and Spanish.
February 28, 2012 (FDA) Important safety changes to the labeling for some widely used cholesterol-lowering drugs known as statins are being announced today by the U.S. Food and Drug Administration.These products, when used with diet and exercise, help to lower a persons bad cholesterol (low-density lipoprotein cholesterol). The products include: Lipitor (atorvastatin), Lescol (fluvastatin), Mevacor (lovastatin), Altoprev (lovastatin extended-release), Livalo (pitavastatin), Pravachol (pravastatin), Crestor (rosuvastatin), and Zocor (simvastatin). Combination products include: Advicor (lovastatin/niacin extended-release), Simcor (simvastatin/niacin extended-release), and Vytorin (simvastatin/ezetimibe).We want health care professionals and patients to have the most current information on the risks of statins, but also to assure them that these medications continue to provide an important health benefit of lowering cholesterol, said Mary Parks, M.D., director for the Division of Metabolism and Endocrinology Products in the Office of Drug Evaluation II in FDAs Center for Drug Evaluation and Research. The changes to the statin labels are:The drug labels have been revised to remove the need for routine periodic monitoring of liver enzymes in patients taking statins. FDA now recommends that liver enzyme tests should be performed before starting statin therapy, and as clinically indicated thereafter. FDA has concluded that serious liver injury with statins is rare and unpredictable in individual patients, and that routine periodic monitoring of liver enzymes does not appear to be effective in detecting or preventing this rare side effect. Patients should notify their health care professional immediately if they have the following symptoms of liver problems: unusual fatigue or weakness; loss of appetite; upper belly pain; dark-colored urine; yellowing of the skin or the whites of the eyes.Certain cognitive (brain-related) effects have been reported with statin use. Statin labels will now include information about some patients experiencing memory loss and confusion. These reports generally have not been serious and the patients symptoms were reversed by stopping the statin. However, patients should still alert their health care professional if these symptoms occur.Increases in blood sugar levels (hyperglycemia) have been reported with statin use. The FDA is also aware of studies showing that patients being treated with statins may have a small increased risk of increased blood sugar levels and of being diagnosed with type 2 diabetes mellitus. The labels will now warn healthcare professionals and patients of this potential risk.Health care professionals should take note of the new recommendations in the lovastatin label. Some medicines may interact with lovastatin, increasing the risk for muscle injury (myopathy/rhabdomyolysis). For example, certain medicines should never be taken (are contraindicated) with Mevacor (lovastatin) including drugs used to treat HIV (protease inhibitors) and drugs used to treat certain bacterial and fungal infections.Reporting side effects to the FDA is important. Health care professionals and patients should report any side effects associated with statin use to FDA MedWatch program.For more information:FDA Drug Safety Communication: Important safety changes for the class of cholesterol-lowering statin drugsFDA Expands Advice on Statin RisksFDA Voice BlogThe FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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